Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to determine the safety and effectiveness of Darbepoetin (Aranesp) given every 14 to 28 days to treat low red blood cells in children with chronic kidney failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• diagnosis of chronic renal insufficiency or end stage renal disease (ESRD) requiring dialysis

• clinically stable

• hemoglobin of 110-125 g/L in screening period; for naive subjects, hemoglobin < 110 g/L

• not iron deficient (TSAT > 19.5%) within 4 weeks of study entry

• stable darbepoetin alpha therapy administered IV or SC q7 to q21 days OR darbepoetin alpha naive

• written informed consent from parent/legal guardian

• less than 18 years old

• weight at least 10 kg

• females of childbearing potential must practice adequate contraception

• availability for follow-up assessments

Exclusion Criteria:

• scheduled for a living donor kidney transplant within 12 weeks of signing consent

• uncontrolled blood pressure as judged by principal investigator

• change in seizure pattern in past 30 days; grand-mal seizure 12 weeks before enrollment

• current clinical evidence of severe hyperparathyroidism

• major surgery 2 weeks before signing consent

• active inflammatory disease or condition requiring immunosuppressive therapy

• currently receiving antibiotics for active systemic infection

• peritoneal dialysis patient with an episode of peritonitis within the past 30 days

• known HIV antibody positivity

• known antibodies to rHuEPO

• known aluminum toxicity

• known red cell aplasia

• known malignancy